[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Rules and Regulations]
[Pages 17397-17401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 
1020

[Docket No. 2007N-0104]


Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending certain 
medical device regulations to correct typographical errors and to 
ensure accuracy and clarity in the agency's regulations.

EFFECTIVE DATE:  April 9, 2007.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2343.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 
803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 to correct 
typographical errors, and update addresses, telephone numbers, and 
wording to ensure accuracy and clarity in the agencies medical device 
regulations.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because these 
errors are nonsubstantive.

I. Highlights of the Final Rule

    FDA is making changes to correct typographical and other minor 
errors in certain device regulations in parts 803, 814, 820, 821, 822, 
874, 886, 1002, 1005, and 1020 (21 CFR 803, 814, 820, 821, 822, 874, 
886, 1002, 1005, and 1020).
    1. FDA is revising Sec.  803.11 and replacing ``301-443-8818'' with 
``240-276-3151.''
    2. FDA is revising Sec.  803.11 and replacing ``http://www.fda.gov/cdrh/mdr/mdr-forms.html'' with ``http://www.fda.gov/medwatch/getforms.htm.''
    3. FDA is revising Sec.  803.21(a) and replacing ``301-443-8818'' 
with ``240-276-3151.''
    4. FDA is revising Sec.  803.21(a) and replacing ``http://www.fda.gov/cdrh/mdr/373.html'' with ``http://www.fda.gov/cdrh/mdr/mdr-forms.html.''
    5. FDA is revising Sec.  814.20(g) and replacing ``FDA has issued a 
PMA guidance document to assist the applicant in the arrangement and 
content of a PMA. This guidance document is available on the Internet 
at http://www.fda.gov/cdrh/dsma/pmaman/front.html. This guidance 
document is also available upon request from the Center for Devices and 
Radiological Health, Division of Small Manufacturers Assistance (HFZ-
220), 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818'' with 
``Additional information on FDA policies and procedures, as well as 
links to PMA guidance documents, is available on the Internet at http://www.fda.gov/cdrh/devadvice/pma/.''
    6. FDA is revising Sec.  820.1(e) and replacing ``Division of Small

[[Page 17398]]

Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 
20850, U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-
8818'' with ``Division of Small Manufacturers, International and 
Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, 
U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.''
    7. FDA is revising Sec.  821.2(c) and removing the words ``and 
Surveillance.''
    8. FDA is revising Sec.  822.7(b) and replacing ``(www.fda.gov/cdrh/resolvingdisputes), and from the CDRH Facts-on-Demand system (800-
899-0381 or 301-827-0111)'' with ``(http://www.fda.gov/cdrh/ombudsman/dispute.html).''
    9. FDA is revising Sec.  822.15 and replacing ``You may obtain 
guidance regarding dispute resolution procedures from the Center for 
Devices and Radiological Health's (CDRH) Web site (www.fda.gov/cdrh/resolvingdisputes/ombudsman.html) and from the CDRH Facts-on-Demand 
system (800-899-0381 or 301-827-0111, document number 1121)'' with 
``You may obtain guidance regarding dispute resolution procedures from 
the Center for Devices and Radiological Health's (CDRH's) Web site 
(www.fda.gov/cdrh/ombudsman/).''
    10. FDA is revising Sec.  822.22(b) and replacing ``You may obtain 
guidance documents that discuss these mechanisms from the CDRH Web site 
and from the CDRH Facts-on-Demand System (800-899-0381 or 301-827-
0111)'' with ``You may obtain guidance documents that discuss these 
mechanisms from the Center for Devices and Radiological Health's 
(CDRH's) Web site.''
    11. FDA is revising Sec.  874.4420 and replacing ``tonsil suction 
tub'' with ``tonsil suction tube.''
    12. FDA is revising Sec.  874.4420 and replacing ``ear suction 
tub'' with ``ear suction tube.''
    13. FDA is revising the section title in Sec.  886.1090 and 
replacing ``Haidlinger'' with ``Haidinger.''
    14. FDA is revising Sec.  886.1090(a) and replacing ``Haidlinger'' 
with ``Haidinger.''
    15. FDA is revising Sec.  1002.7 and replacing ``shall be addressed 
to the Center for Devices and Radiological Health, Electronic Product 
Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, 
MD 20850'' with ``shall be addressed to the Center for Devices and 
Radiological Health, ATTN: Electronic Product Reports, Radiological 
Health Document Control (HFZ-309), Office of Communication, Education, 
and Radiation Programs, 9200 Corporate Blvd, Rockville, MD 20850.
    16. FDA is revising Sec.  1002.10 and replacing ``Center for 
Devices and Radiological Health, Electronic Product Reports, Office of 
Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850'' with 
``Center for Devices and Radiological Health, ATTN: Electronic Product 
Reports, Radiological Health Document Control (HFZ-309), Office of 
Communication, Education, and Radiation Programs, 9200 Corporate Blvd, 
Rockville, MD 20850.''
    17. FDA is revising Sec.  1002.20(b) and replacing ``Director, 
Center for Devices and Radiological Health, 5600 Fishers Lane, 
Rockville, MD 20857'' with ``Center for Devices and Radiological 
Health, ATTN: Accidental Radiation Occurrence Reports (HFZ-240), Office 
of Communication, Education, and Radiation Programs, 9200 Corporate 
Boulevard, Rockville, MD 20850.''
    18. FDA is revising Sec.  1002.50(c)(3) and replacing ``Office of 
Compliance (HFZ-307)'' with ``Office of Communication, Education, and 
Radiation Programs (HFZ-240).''
    19. FDA is revising Sec.  1005.11 and replacing ``5600 Fishers 
Lane, Rockville, MD 20857'' with ``(HFZ-204), 9200 Corporate Blvd., 
Rockville, MD 20857.''
    20. FDA is revising Sec.  1005.25(b) and adding ``(HFZ-240).''
    21. FDA is revising Sec.  1020.30(c) and replacing ``Office of 
Compliance and Surveillance'' with ``Office of Communication, 
Education, and Radiation Programs.''

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(i) that this final 
rule is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement was 
required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule corrects only typographical and 
nonsubstantive errors in existing regulations and does not change in 
any way how devices are regulated, the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $122 million, using the most current (2005) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Paperwork Reduction Act of 1995

    FDA has determined that this final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VI. The Technical Amendments

    This rule updates and corrects existing regulations to ensure 
accuracy and clarity. This administrative action is limited to 
correcting typographical errors; updating changes in addresses, web 
site locations, and telephone numbers; and clarifying regulation 
terminology. It makes no changes in substantive requirements.
    For the effective date of this final rule see EFFECTIVE DATE. 
Because this final

[[Page 17399]]

rule is an administrative action, FDA has determined that it has no 
substantive impact on the public. It imposes no costs, and merely makes 
technical administrative changes in the Code of Federal Regulations 
(CFR) for the convenience of the public. FDA, therefore, for good 
cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and 
public comment are unnecessary.

List of Subjects

21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 820

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 874

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

21 CFR Part 1005

    Administrative practice and procedure, Electronic products, 
Imports, Radiation protection, Surety bonds.

21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection, 
Reporting and recordkeeping requirements, Television, X-rays.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 are amended as 
follows:

PART 803--MEDICAL DEVICE REPORTING

0
1. The authority section for part 803 continues to read as follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

0
2. Section 803.11 is revised to read as follows:


Sec.  803.11  What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?

    If you are a user facility, importer, or manufacturer, you must 
submit all reports of individual adverse events on FDA MEDWATCH Form 
3500A or in an electronic equivalent as approved under Sec.  803.14. 
You may obtain this form and all other forms referenced in this section 
from any of the following:
    (a) The Consolidated Forms and Publications Office, Beltsville 
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
    (b) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7240;
    (c) Division of Small Manufacturers, International, and Consumer 
Assistance, Office of Communication, Education, and Radiation Programs, 
Center for Devices and Radiological Health (CDRH) (HFZ-220), 1350 
Piccard Dr. Rockville, MD 20850, by e-mail: <a href="/cdn-cgi/l/email-protection#df9b8c92969c9e9f9c9b8d97f1999b9ef1989089"><span class="__cf_email__" data-cfemail="692d3a24202a28292a2d3b21472f2d28472e263f">[email protected]</span></a>, or 
FAX: 240-276-3151;
    (d) On the Internet at http://www.fda.gov/medwatch/getforms.htm.

0
3. In Sec.  803.21, paragraph (a) is revised to read as follows:


Sec.  803.21  Where can I find the reporting codes for adverse events 
that I use with medical device reports?

    (a) The MEDWATCH Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with FDA Form 3500A. You may 
obtain the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/mdr-forms.html; and from the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 240-
276-3151, or e-mail to <a href="/cdn-cgi/l/email-protection#4e0a1d03070d0f0e0d0a1c0660080a0f60090118"><span class="__cf_email__" data-cfemail="d59186989c9694959691879dfb939194fb929a83">[email protected]</span></a>.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
4. The authority section for part 814 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

0
5. In Sec.  814.20, paragraph (g) is revised to read as follows:


Sec.  814.20  Application.

* * * * *
    (g) Additional information on FDA policies and procedures, as well 
as links to PMA guidance documents, is available on the Internet at 
http://www.fda.gov/cdrh/devadvice/pma/.
* * * * *

PART 820--QUALITY SYSTEMS REGULATION

0
6. The authority section for part 820 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383.

0
7. In Sec.  820.1, paragraph (e)(1) is revised to read as follows:


Sec.  820.1  Scope.

* * * * *
    (e) Exemptions or variances. (1) Any person who wishes to petition 
for an exemption or variance from any device quality system requirement 
is subject to the requirements of section 520(f)(2) of the act. 
Petitions for an exemption or variance shall be submitted according to 
the procedures set forth in Sec.  10.30 of this chapter, the FDA's 
administrative procedures. Guidance is available from the Center for 
Devices and Radiological Health, Division of Small Manufacturers, 
International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., 
Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, 
FAX 240-276-3151.
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

0
8. The authority section for part 821 continues to read as follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.

0
9. In Sec.  821.2, paragraph (c) is revised to read as follows:


Sec.  821.2  Exemptions and variances.

* * * * *
    (c) An exemption or variance is not effective until the Director, 
Office of Compliance, CDRH, approves the request under Sec.  
10.30(e)(2)(i) of this chapter.

PART 822--POSTMARKET SURVEILLANCE

0
10. The authority section for part 822 continues to read as follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
11. In Sec.  822.7, paragraph (b) is revised to read as follows:


Sec.  822.7  What should I do if I do not agree that postmarket 
surveillance is appropriate?

* * * * *

[[Page 17400]]

    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web site 
(http://www.fda.gov/cdrh/ombudsman/dispute.html).

0
12. Section 822.15 is revised to read as follows:


Sec.  822.15  How long must I conduct postmarket surveillance of my 
device?

    The length of postmarket surveillance will depend on the postmarket 
surveillance question identified in our order. We may order prospective 
surveillance for a period up to 36 months; longer periods require your 
agreement. If we believe that a prospective period of greater than 36 
months is necessary to address the surveillance question, and you do 
not agree, we will use the Medical Devices Dispute Resolution Panel to 
resolve the matter. You may obtain guidance regarding dispute 
resolution procedures from the Center for Devices and Radiological 
Health's (CDRH') Web site (www.fda.gov/cdrh/ombudsman/). The 36-month 
period refers to the surveillance period, not the length of time from 
the issuance of the order.

0
13. In Sec.  822.22, paragraph (b) is revised to read as follows:


Sec.  822.22  What recourse do I have if I do not agree with your 
decision?

* * * * *
    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web 
site.

PART 874--EAR, NOSE, AND THROAT DEVICES

0
14. The authority section for part 874 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
15. In Sec.  874.4420, paragraph (a) is revised to read as follows:


Sec.  874.4420  Ear, nose, and throat manual surgical instrument.

    (a) Identification. An ear, nose, and throat manual surgical 
instrument is one of a variety of devices intended for use in surgical 
procedures to examine or treat the bronchus, esophagus, trachea, 
larynx, pharynx, nasal and paranasal sinus, or ear. This generic type 
of device includes the esophageal dilator; tracheal bistour (a long, 
narrow surgical knife); tracheal dilator; tracheal hook; laryngeal 
injection set; laryngeal knife; laryngeal saw; laryngeal trocar; 
laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; 
mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil 
guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil 
suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; 
nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; 
nasal snare; sinus irrigator; sinus trephine; ear curette; ear 
excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction 
tube; malleous ripper; mastoid gauge; microsurgical ear chisel; 
myringotomy tube inserter; ossici holding clamp; sacculotomy tack 
inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, 
nose, and throat punch; ear, nose and throat knife; and ear, nose, and 
throat trocar.
* * * * *

PART 886--OPHTHALMIC DEVICES

0
16. The authority section for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
17. In Sec.  886.1090, the section title and paragraph (a) are revised 
to read as follows:


Sec.  886.1090  Haidinger brush.

    (a) Identification. A Haidinger brush is an AC-powered device that 
provides two conical brushlike images with apexes touching which are 
viewed by the patient through a Nicol prism and intended to evaluate 
visual function. It may include a component for measuring macular 
integrity.
* * * * *

PART 1002--RECORDS AND REPORTS

0
18. The authority section for part 1002 continues to read as follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374.

0
19. In Sec.  1002.7, the introductory text is revised to read as 
follows:


Sec.  1002.7  Submission of data and reports.

    All submissions such as reports, test data, product descriptions, 
and other information required by this part, or voluntarily submitted 
to the Director, Center for Devices and Radiological Health, shall be 
filed with the number of copies as prescribed by the Director, Center 
for Devices and Radiological Health, and shall be signed by the person 
making the submission. The submissions required by this part shall be 
addressed to the Center for Devices and Radiological Health, ATTN: 
Electronic Product Reports, Radiological Health Document Control (HFZ-
309), Office of Communication, Education, and Radiation Programs, 9200 
Corporate Blvd., Rockville, MD 20850.
* * * * *

0
20. In Sec.  1002.10, the introductory text is revised to read as 
follows:


Sec.  1002.10  Product reports.

    Every manufacturer of a product or component requiring a product 
report as set forth in table 1 of Sec.  1002.1 shall submit a product 
report to the Center for Devices and Radiological Health, ATTN: 
Electronic Product Reports, Radiological Health Document Control (HFZ-
309), Office of Communication, Education, and Radiation Programs, 9200 
Corporate Blvd., Rockville, MD 20850, prior to the introduction of such 
product into commerce. The report shall be distinctly marked 
``Radiation Safety Product Report of (name of manufacturer)'' and 
shall:
* * * * *

0
21. In Sec.  1002.20, paragraph (b) is revised to read as follows:


Sec.  1002.20  Reporting of accidental radiation occurrences.

* * * * *
    (b) Such reports shall be addressed to the Center for Devices and 
Radiological Health, ATTN: Accidental Radiation Occurrence Reports 
(HFZ-240), Office of Communication, Education, and Radiation Programs, 
9200 Corporate Blvd., Rockville, MD 20850, and the reports and their 
envelopes shall be distinctly marked ``Report on 1002.20'' and shall 
contain all of the following information where known to the 
manufacturer:
    (1) The nature of the accidental radiation occurrence;
    (2) The location at which the accidental radiation occurrence 
occurred;
    (3) The manufacturer, type, and model number of the electronic 
product or products involved;
    (4) The circumstances surrounding the accidental radiation 
occurrence, including causes;
    (5) The number of persons involved, adversely affected, or exposed 
during the accidental radiation occurrence, the nature and magnitude of 
their exposure and/or injuries and, if requested by the Director, 
Center for Devices and Radiological Health, the names of the persons 
involved;
    (6) The actions, if any, which may have been taken by the 
manufacturer, to control, correct, or eliminate the causes and to 
prevent reoccurrence; and

[[Page 17401]]

    (7) Any other pertinent information with respect to the accidental 
radiation occurrence.
* * * * *

0
22. In Sec.  1002.50, paragraph (c)(3) is revised to read as follows:


Sec.  1002.50  Special exemptions.

* * * * *
    (c) * * *
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall be available upon request 
from the Center for Devices and Radiological Health, Office of 
Communication, Education, and Radiation Programs (HFZ-240), 9200 
Corporate Blvd., Rockville, MD 20850.
* * * * *

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
23. The authority section for part 1005 continues to read as follows:

    Authority: 42 U.S.C. 263d, 263h.

0
24. Section 1005.11 is revised to read as follows:


Sec.  1005.11  Payment for samples.

    The Department of Health and Human Services will pay for all import 
samples of electronic products rendered unsalable as a result of 
testing, or will pay the reasonable costs of repackaging such samples 
for sale, if the samples are found to be in compliance with the 
requirements of the Radiation Control for Health and Safety Act of 
1968. Billing for reimbursement shall be made by the owner or consignee 
to the Center for Devices and Radiological Health (HFZ-204), 9200 
Corporate Blvd., Rockville, MD 20857. Payment for samples will not be 
made if the sample is found to be in violation of the Act, even though 
subsequently brought into compliance pursuant to terms specified in a 
notice of permission issued under Sec.  1005.22.

0
25. In Sec.  1005.25, paragraph (b) is revised to read as follows:


Sec.  1005.25  Service of process on manufacturers.

* * * * *
    (b) A manufacturer designating an agent must address the 
designation to the Center for Devices and Radiological Health (HFZ-
240), 9200 Corporate Blvd., Rockville, MD 20850. It must be in writing 
and dated; all signatures must be in ink. The designation must be made 
in the legal form required to make it valid and binding on the 
manufacturer under the laws, corporate bylaws, or other requirements 
governing the making of the designation by the manufacturer at the 
place and time where it is made, and the persons or person signing the 
designation shall certify that it is so made. The designation must 
disclose the manufacturer's full legal name and the name(s) under which 
the manufacturer conducts the business, if applicable, the principal 
place of business, and mailing address. If any of the products of the 
manufacturer do not bear his legal name, the designation must identify 
the marks, trade names, or other designations of origin which these 
products bear. The designation must provide that it will remain in 
effect until withdrawn or replaced by the manufacturer and shall bear a 
declaration of acceptance duly signed by the designated agent. The full 
legal name and mailing address of the agent must be stated. Until 
rejected by the Secretary, designations are binding on the manufacturer 
even when not in compliance with all the requirements of this section. 
The designated agent may not assign performance of his function under 
the designation to another.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
26. The authority section for part 1020 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381.

0
27. In Sec.  1020.30, paragraph (c) is revised to read as follows:


Sec.  1020.30  Diagnostic x-ray systems and their major components.

* * * * *
    (c) Manufacturers' responsibility. Manufacturers of products 
subject to Sec. Sec.  1020.30 through 1020.33 shall certify that each 
of their products meet all applicable requirements when installed into 
a diagnostic x-ray system according to instructions. This certification 
shall be made under the format specified in Sec.  1010.2 of this 
chapter. Manufacturers may certify a combination of two or more 
components if they obtain prior authorization in writing from the 
Director of the Office of Communication, Education, and Radiation 
Programs of the Center for Devices and Radiological Health. 
Manufacturers shall not be held responsible for noncompliance of their 
products if that noncompliance is due solely to the improper 
installation or assembly of that product by another person; however, 
manufacturers are responsible for providing assembly instructions 
adequate to assure compliance of their components with the applicable 
provisions of Sec. Sec.  1020.30 through 1020.33.
* * * * *

    Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6290 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S?>


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